The following data is part of a premarket notification filed by Physicians Consulting, Inc. with the FDA for Krdl 2000.
| Device ID | K944819 |
| 510k Number | K944819 |
| Device Name: | KRDL 2000 |
| Classification | Exerciser, Powered |
| Applicant | PHYSICIANS CONSULTING, INC. 100 CONGRESS, SUITE 1010 Austin, TX 78701 -4042 |
| Contact | Gregory E Johnson |
| Correspondent | Gregory E Johnson PHYSICIANS CONSULTING, INC. 100 CONGRESS, SUITE 1010 Austin, TX 78701 -4042 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-03-10 |